WebMD’s consumer STD lab tests came under fire this week after Responsible Telemedicine, a nonprofit that bills itself as an "industry watchdog," filed a lawsuit suing the company for mislabeling the tests as FDA approved.
The suit alleges that only three of the nine STD tests sold by WebMD have “undergone the United States Food and Drug Administration (FDA) premarket approval process through which the FDA can 'approve' a laboratory testing assay.”
The lawsuit goes on to allege that five of the nine tests — including those for syphilis, hepatitis A, chlamydia and gonorrhea, herpes 1 & and trichomonais (female) — have been cleared, rather than approved, through the less stringent process of premarket notification. It also claims the trichomonais (male) test hasn’t gone through FDA regulation or approval.
"To misrepresent the level of approval process that a clinical diagnostic assay has gone through with the FDA is a gross misrepresentation and breach of patient trust, and it goes entirely against the best interest of the consumer. It is our responsibility to improve the quality of telemedicine practiced in this digital age, and what WebMD is doing feels counterintuitive to that effort," Aadel Sarfani, executive director of Responsible Telemedicine, said in a statement.
Additionally, the nonprofit accuses WebMD of claiming that a physician will conduct a review to determine if the testing is appropriate. However, the suit said patients aren’t asked for their medical history or conditions, which would make such a review impossible.
MobiHealthNews has reached out to WebMD for a comment and will update this story accordingly.
WHY IT MATTERS
Telemedicine and digital health are still in many ways the new kids on the block in the healthcare field. In turn the industry is still carving out its space seeking out legitimacy in the broader healthcare space.
"Trust is an important foundation of telemedicine. When a well-respected source in the medical field, like WebMD, breaks patients' trust, quick and swift action must be taken. Responsible Telemedicine is going to look for answers when big-name companies make false claims and mislead patients in the pursuit of profit," Sarfani said in a statement.
THE LARGER TREND
This is hardly the first time that a digital health company has faced legal action. Most recently uBiome, a pioneer of direct-to-consumer microbiome testing, was in the news last month after the FBI launched an investigation into the company. CNBC and STAT News suggested the company is being investigated for fraudulent insurance billing practices, possibly including double-billing insurance for tests, using improper billing codes or compensating telemedicine physicians who refer patients to uBiome in an illegal way.